Apparatus and method for sterilization of an article

ABSTRACT

An apparatus and method for sterilization of an article which has a first open end, a second open end and a lumen extending therebetween. The apparatus comprises a first chamber for receiving the article. The first chamber has an outlet fluidly connectable to a pump for adjusting an internal pressure in the first chamber; and an inlet fluidly connectable to a sterilant source for supplying sterilant to the first chamber. The apparatus includes a second chamber fluidly connectable to the first chamber by a chamber connector fluidly sealable to isolate the first and the second chamber; and an article connector for fluidly connecting the second open end of the article to the second chamber to form a fluid path from the first to the second chamber through the lumen. Also included is an article connector for connecting an open end of an article to be sterilized to a sterilization apparatus.

CROSS-REFERENCE

This application is a continuation of U.S. patent application Ser. No.16/349,945, filed on May 14, 2019, which is a 371 of InternationalPatent Application No. PCT/CA2017/051362 filed on Nov. 15, 2017, whichclaims the benefit of U.S. Provisional Patent Application No. 62/422,493filed Nov. 15, 2016. The contents of each of the aforementionedapplications are incorporated by reference herein in their entirety.

TECHNICAL FIELD

The present technology relates to an apparatus and a method forsterilization of an article, and to an article connector for connectingan article to be sterilized to a sterilization apparatus.

BACKGROUND

The proper sterilization of reusable articles for medical use is acritical consideration in preventing transmission of diseases betweenpatients. Sterilization techniques for such articles include thoseinvolving high temperature, such as steam and dry heat, chemicalsterilants such as ethylene oxide gas and hydrogen peroxide vapour, andirradiation, to name a few. Suitability of any one or more of thesetechniques for sterilization of an article depends on many factorsincluding, but not limited to, the configuration of the article to besterilized such as its shape and size, its suitability for liquidimmersion, and its material composition.

For medical use articles which include a tubular structure having aninternal lumen, sterilization throughout the entire length of the lumencan present difficulties. This can be especially pertinent for articleswith relatively long and narrow lumen, and for articles with a pluralityof lumen. Endoscopes are one example of such articles where diffusion ofsterilant through the entire length of the lumen can present achallenge.

Endoscopes are medical devices which include one or more tubes which canbe inserted into a body cavity of a patient, the tube having an internallumen allowing for various functions such as light transmission forviewing purposes, sample collection from the body cavity, and/orsubstance delivery to the body cavity. Endoscopes can be of flexible,rigid and semi-flexible form, and include but are not limited tobronchoscopes, colonoscopes, intubation scopes, duodenoscopes,gastroscopes, and sigmoidoscopes. The endoscope tubes may be as long as3.5 metres and have internal lumen diameters as narrow as 0.7 mmdiameter. Multi-lumen endoscopes may have up to 8 lumens. As such, someendoscopes have long and narrow lumen(s) that are difficult to sterilizeusing known techniques.

Many endoscopes are heat-sensitive articles and so do not lendthemselves to sterilization techniques involving high temperatures.Ethylene gas oxide based techniques involve toxic, carcinogen andflammable products, and require lengthy sterilization cycles and so arenot ideal. Liquid chemical techniques have a number of disadvantagesincluding a requirement to rinse the chemical residues which cancompromise the sterility, and unsuitability for non-immersible endoscopedesigns. Hydrogen peroxide leaves no toxic residues and can be used forheat and moisture sensitive items but, in the past, has had limitedsuccess in sterilizing articles having relatively long and narrow lumenand in sterilizing articles with multi-lumen, particularly those withmore than 2 lumen.

Furthermore, in certain sterilization techniques, a portion of thearticle to be sterilized may require a connection to the sterilizationapparatus or support within the sterilization apparatus. This can resultin occluded connection points between the article and the sterilizationapparatus leaving unsterilized areas on the article.

The incomplete sterilization of an article such as an endoscope can befatal. Reported cases of patient infection with antimicrobial resistantbacteria have been attributed to incomplete sterilization ofduodenoscopes. This led to a U.S. Food and Drug Administration SafetyCommunication in 2015(http://www.fda.gov/MedicalDevices/Safety/AlertsandNotices/ucm454766.htm)recommending supplemental measures to consider when reprocessingduodensoscopes. These measures included the use of sterilizingtechniques using a chemical sterilant after cleaning and high leveldisinfection, as well as microbiological culturing involving samplingduodenoscope lumens and the distal end of the duodenoscope and culturingthose samples to identify any bacterial contamination that may bepresent on the duodenoscope after reprocessing. However, verifying thesterility of each article is expensive and slow, with the article inquestion requiring quarantine until the test results are obtained.

Therefore, there is a need for an apparatus and a method for sterilizingan article, such as an article with a lumen, e.g. an endoscope, thatwould reduce, minimize or alleviate one or more of the problemsassociated with current sterilization methods and apparatus.

SUMMARY

It is an object of the present to ameliorate at least some of theinconveniences present in the prior art.

According to an aspect of the present technology, there is provided anapparatus for sterilization of an article, the article having a firstopen end, a second open end and a lumen extending therebetween, theapparatus comprising: a first chamber for receiving the article, thefirst chamber having an outlet which is fluidly connectable to a pumpfor adjusting an internal pressure in the first chamber, an inlet whichis fluidly connectable to a sterilant source for supplying sterilant tothe first chamber; a second chamber fluidly connectable to the firstchamber by a chamber connector, the chamber connector being selectivelysealable to fluidly isolate the first and second chambers; and anarticle connector configured to fluidly connect the second open end ofthe article to the second chamber to form a fluid path extending fromthe first chamber to the second chamber through the lumen of thearticle.

From another aspect, there is provided an apparatus for sterilization ofan article, the article having a first open end, a second open end and alumen extending therebetween, the apparatus comprising: a first chamberfor receiving the article, the first chamber having an outlet which isfluidly connectable to a pump for adjusting an internal pressure in thefirst chamber, and an inlet which is fluidly connectable to a sterilantsource for supplying sterilant to the first chamber; a second chamberdisposed outside of the first chamber and fluidly connectable to thefirst chamber by a chamber connector; and an article connectorconfigured to fluidly connect the second open end of the article to thesecond chamber to form a fluid path extending from the first chamber tothe second chamber through the lumen of the article.

From a further aspect, there is provided an apparatus for sterilizationof an article, the article having a first open end, a second open endand a lumen extending therebetween, the apparatus comprising: a firstchamber for receiving the article, the first chamber having an outletwhich is fluidly connectable to a pump for adjusting an internalpressure in the first chamber, an inlet which is fluidly connectable toa sterilant source for supplying sterilant to the first chamber; asecond chamber fluidly connectable to the first chamber by a chamberconnector; an article connector configured to fluidly connect the secondopen end of the article to the second chamber to form a fluid pathextending from the first chamber to the second chamber through the lumenof the article, and an inlet in at least one of the first or secondchamber for connection to a fluid source which can be supplied to thelumen of the article for adjusting the temperature of the article inuse.

In certain embodiments of any of the preceding or foregoing aspects, theapparatus further comprises at least one or more of the pump, thesterilant source, and a vaporizer for vaporizing the sterilant.

In certain embodiments of any of the preceding or foregoing aspects, thechamber connector comprises a valve which is configurable between anopen and a closed position for fluidly connecting and isolating thefirst and second chambers. The article connector can be connectable tothe second chamber by the chamber connector, or in another manner.

In certain embodiments of any of the preceding or foregoing aspects, theapparatus further comprises a by-pass conduit to fluidly connect thefirst chamber to the second chamber, separate from the chamberconnector, and to selectively allow fluid flow from the second chamberto the first chamber.

In certain embodiments of any of the preceding or foregoing aspects, theinlet is configurable to selectively supply air to the first chamber.The first chamber can further comprise an auxiliary inlet for allowingfluid, such as air, to flow into the first chamber. This can increasethe pressure in the first chamber.

In certain embodiments of any of the preceding or foregoing aspects,there is no direct connection from the second chamber to the pump. Thefluid path to and from the second chamber may extend only through thefirst chamber which is connectable to the pump.

In certain embodiments of any of the preceding or foregoing aspects, theapparatus further comprises a container for housing the article, thecontainer being receivable in the first chamber and having a containeroutlet through which the article connector is fluidly connectable to thesecond chamber, and a container inlet arranged to allow ingress of asterilant. The container can comprise a box having walls and a lid; andthe container inlet can comprise a porous area in at least one of thewalls and the lid arranged to allow ingress of the sterilant inside thecontainer and to prevent microbial ingress inside the container. Thecontainer can further comprises a container connector at the containeroutlet which is arranged to fluidly connect at least one of the secondopen end of the article and the article connector, to the chamberconnector. The container connector may comprise a valve for preventingfluid communication therethrough when the container connector isdisconnected from the chamber connector, or a membrane which issterilant permeable and microorganism impermeable. In certainembodiments, the container connector comprises an array of containerconnector ports, each container connector port being fluidly connectableat one end to the article connector and at the other end to the chamberconnector.

In certain embodiments of any of the preceding or foregoing aspects, thearticle comprises a plurality of second open ends, and the apparatusfurther comprises a plurality of article connectors for connecting atleast one of the plurality of second open ends of the article to atleast one of the container connector ports. The chamber connector maycomprise an array of chamber connector ports, at least one of thechamber connector ports being fluidly connectable to at least one of thecontainer connector port. A conduit may be provided between at least oneof the chamber connector ports and a corresponding container connectorport. In certain embodiments, at least one of the chamber connectorports has an associated chamber connector valve, the chamber connectorvalves being separately controllable.

In certain embodiments of any of the preceding or foregoing aspects, thesecond chamber has a volume which is larger than a volume of the fluidpath extending from the first open end of the article, through the lumenof the article and to the chamber connector.

In certain embodiments of any of the preceding or foregoing aspects, thesecond chamber comprises a plurality of compartments, each one of theplurality of compartments being fluidly connectable to the first chamberthrough a corresponding one of the chamber connector ports of thechamber connector. At least one of the plurality of compartments mayfurther comprise a by-pass conduit to fluidly connect the first chamberto the at least one of the plurality of compartments of the secondchamber. At least one of the plurality of the compartments of the secondchamber may have a volume which is larger than a volume of the fluidpath extending from the first open end of the article, through the lumenof the article and to the chamber connector.

In certain embodiments of any of the preceding or foregoing aspects, thesecond chamber comprises a second chamber inlet which is fluidlyconnectable to a fluid source for supplying fluid to the lumen of thearticle, which may be through the first or second chamber. The fluidsource may be arranged to supply air having a temperature of betweenabout 30° C. and about 200° C., about 60° C. to about 100° C., or about80° C. to about 95° C.

In certain embodiments of any of the preceding or foregoing aspects, theapparatus further comprises an atmosphere monitoring device formonitoring a parameter of the atmosphere in at least one of the firstand second chambers. In certain embodiments, the sterilant is hydrogenperoxide vapour.

In certain embodiments of any of the preceding or foregoing aspects, thesecond chamber is disposed outside of the first chamber, or at leastpartially inside the first chamber. The second chamber may be containedwithin a housing which can be maintained at substantially atmosphericpressure.

In certain embodiments of any of the preceding or foregoing aspects,wherein the article connector comprises a body having a longitudinalaxis and an inner surface defining an axially elongate bore extendingtherethrough, the body having a female portion configured to receivetherein the second open end of the article, and a male portion extendingfrom the female portion and configured to be connectable with a portionof the first or second chamber; an annular recessed portion defined inthe inner surface of the female portion, the annular recessed portionbeing axially aligned with the body; at least one annular member whichis at least partially receivable in the annular recessed portion; and atleast one opening extending through the body to form a fluidcommunication between the elongate bore and an outer surface of thebody.

From a further aspect, there is provided an apparatus for sterilizationof an article, the article having a first open end, a second open endand a lumen extending therebetween, the apparatus comprising: a firstchamber for receiving the article, the first chamber having an outletwhich is fluidly connectable to a pump for adjusting an internalpressure in the first chamber; a sterilant inlet which is fluidlyconnectable to a sterilant source for supplying sterilant to the firstchamber, the sterilant being hydrogen peroxide; and a warm fluid inletin the first chamber for connection to a fluid source adjusting thetemperature of the article in use. In certain embodiments, the fluidsource is warm air which is supplied to the first chamber before thearticle is exposed to the sterilant. In certain embodiments, the firstchamber may include an article connector for fluidly connecting thesecond open end of the article to the warm fluid inlet.

From another aspect, there is provided a kit for retroactively adaptingan existing sterilization chamber to the aspects and embodiments of theapparatus described above. In certain embodiments, the existingsterilization chamber is a pressure chamber and the kit comprises areplacement door, wall or panel (hereinafter referred to as ‘panel’) forthe existing sterilization chamber. The panel may comprise any one ormore of a second chamber fluidly connectable to a chamber connector, thechamber connector being selectively sealable to fluidly isolate thefirst and second chambers. The replacement door, wall or panel may alsoinclude a by-pass conduit between the existing sterilization chamber andthe second chamber for further fluidly connecting the first and secondchambers separately from the chamber connector. The replacement door,wall or panel may include a fluid connection to a warm air source forwarming the lumen of the article.

In certain embodiments of any of the preceding or foregoing aspects, thereplacement panel comprises an outer compartment for housing a secondpressure chamber, the second chamber being fluidly connectable to achamber connector which is selectively sealable to fluidly isolate thefirst and second chambers. The replacement panel may be configured suchthat when the panel is positioned on the existing sterilization chamber,the outer compartment and the second chamber are disposed inside theexisting sterilization chamber.

In certain embodiments of any of the preceding or foregoing aspects, aby-pass conduit can be provided between the existing sterilizationchamber and the second chamber for further fluidly connecting the firstand second chambers separately from the chamber connector. Thereplacement panel may include a fluid connection to a warm air sourcefor warming the lumen of the article.

In certain embodiments of any of the preceding or foregoing aspects, anarticle connector is provided for fluidly connecting a second open endof an article to the chamber connector.

In certain embodiments of any of the preceding or foregoing aspects, acontainer is provided to house the article to be sterilized, whichcontainer can be fluidly connectable to the chamber connector throughthe article connector.

From a further aspect, there is provided a method for sterilization ofan article having a first open end, a second open end and a lumenextending therebetween, the method comprising the steps of: a) providingthe article in a first chamber of a sterilization apparatus with thefirst open end of the article in fluid communication with the firstchamber; b) forming a fluid path from the first chamber to a secondchamber of the sterilization apparatus through the lumen of the article;c) supplying a sterilant to the first chamber; d) creating a pressuredifference between an internal pressure of the first chamber and aninternal pressure of the second chamber; and e) allowing the sterilantto flow from the first chamber to the second chamber through the lumenof the article. In certain embodiments, the second chamber isselectively sealable to fluidly isolate the first and second chambers.

From a yet further aspect, there is provided a method for sterilizationof an article having a first open end, a second open end and a lumenextending therebetween, the method comprising a) providing a firstchamber for receiving the article, and a second chamber fluidlyconnectable to the first chamber and selectively sealable to fluidlyisolate the first and second chambers; b) disposing the article in thefirst chamber with the first open end in fluid communication with thefirst chamber, and forming a fluid path from the first chamber to thesecond chamber through the lumen of the article; c) supplying asterilant to the first chamber; d) creating a pressure differencebetween an internal pressure of the first chamber and an internalpressure of the second chamber; and e) allowing the sterilant to flowfrom the first chamber to the second chamber through the lumen of thearticle.

In certain embodiments of any of the preceding or foregoing aspects,disposing the article in the first chamber further comprises housing thearticle inside a container and fluidly connecting the second open end ofthe article to a chamber connector through a container outlet.

In certain embodiments of any of the preceding or foregoing aspects,allowing the sterilant to flow from the first chamber to the secondchamber comprises configuring the chamber connector to allow fluid flowfrom the first chamber to the second chamber.

In certain embodiments of any of the preceding or foregoing aspects,before supplying the sterilant to the first chamber, the method furthercomprises reducing the internal pressure of one or more of the first andsecond chambers.

In certain embodiments of any of the preceding or foregoing aspects,reducing the internal pressure of one or more of the first and secondchambers comprises evacuating fluid from one or more of the first andsecond chambers using a pump fluidly connected to the first chamber, andallowing fluid flow from the second chamber to the first chamber througha by-pass conduit between the first and second chambers. The internalpressures of one or more of the first and second chambers can be reducedto about 2 Torr or lower than about 2 Torr.

In certain embodiments of any of the preceding or foregoing aspects,creating a pressure difference between an internal pressure of the firstchamber and an internal pressure of the second chamber comprisessupplying the sterilant to the first chamber until the internal pressurein the first chamber is higher than the internal pressure in the secondchamber. Other fluid can also be provided to the first chamber tofurther increase the pressure, such as air. The air and the sterilantcan be provided to the first chamber in any order.

In certain embodiments of any of the preceding or foregoing aspects, avalve in the chamber connector is configured in an open position forallowing the sterilant to flow from the first chamber to the secondchamber along the fluid path, during supplying the sterilant to thefirst chamber to create the pressure difference between the first andsecond chambers. The allowing of the sterilant to flow from the firstchamber to the second chamber can happen at the same time as supplyingthe sterilant to the first chamber.

In certain embodiments of any of the preceding or foregoing aspects, avalve in the chamber connector is configured in a closed position duringthe supplying of the sterilant to the first chamber. Fluid such as aircan be supplied into the first chamber whilst the chamber connector isclosed to increase the internal pressure inside the first chamber to atarget pressure, or a target pressure difference between the first andsecond chambers. The target pressure difference may be more than about20 Torr. about 20 Torr to about 60 Torr, or about 20 Torr to about 40Torr, or any other pressure difference for causing the sterilant to flowfrom the first chamber to the second chamber. The target pressure may beabove about 0.3 Torr and below a pressure of condensation of thesterilant. The fluid, such as air, can be supplied into the firstchamber through at least one of an inlet and an auxiliary inlet.

In certain embodiments of any of the preceding or foregoing aspects,wherein after the pressure difference has been created, sterilant isallowed to flow from the first chamber to the second chamber along thefluid path by configuring the valve in the chamber connector in an openposition.

In certain embodiments of any of the preceding or foregoing aspects, thechamber connector comprises a plurality of valves fluidly connectable toa plurality of lumens of the article, the method further comprisingopening the plurality of valves allowing the sterilant to flow from thefirst chamber to the second chamber through the plurality of lumens. Theplurality of valves can be opened at the same time, individually or inbatches.

In certain embodiments of any of the preceding or foregoing aspects, themethod further comprises step f) maintaining the article in contact withthe sterilant for an exposure interval, and (optionally) exhausting thesterilant from the first and second chambers after the exposure intervalhas lapsed.

In certain embodiments of any of the preceding or foregoing aspects,steps c) to f) are repeated at least once after the exposure intervalhas lapsed.

In certain embodiments of any of the preceding or foregoing aspects, themethod further comprises monitoring a parameter of the atmosphere insideat least one of the first and second chambers. The parameter can be atleast one of a pressure, a temperature and a sterilant concentration.

In certain embodiments of any of the preceding or foregoing aspects, themethod further comprising, prior to creating the pressure differencebetween the internal pressure of the first chamber and the internalpressure of the second chamber, supplying air having a temperature ofbetween about 30° C. and about 200° C. into the lumen of the article.

From a yet further aspect, there is provided an article connector forconnecting an open end of an article to be sterilized to a sterilizationapparatus, the article connector comprising: a body having alongitudinal axis and an inner surface defining an axially elongate boreextending between two open ends of the body, the body having first andsecond portions, the first portion being configured to be fluidlyconnectable to an open end of the article, and the second portionconfigured to be fluidly connectable to the sterilization apparatus, theelongate bore extending through the first and second portions andfluidly communicable with a lumen of the article to be sterilized inuse; at least one recessed portion defined in the first portion of thebody and extending circumferentially around the body for receiving atleast one annular member for engagement between the first portion of thebody and the article open end in use; and at least one opening extendingthrough the body of the first portion to form a fluid path, through thebody, between an outside of the article connector which is in contactwith a sterilant in use and a mating surface between the open end of thearticle and the article connector in use. In certain embodiments, the atleast one opening extends from an outside surface of the first portionto the elongate bore.

In certain embodiments, the first portion is a female portion and isconfigured for receiving the open end of the article in use. The atleast one opening can extend from an outside surface of the femaleportion to the elongate bore. In certain embodiments, there are twoopenings extending from an outside surface of the female portion to theelongate bore, the two openings being spaced circumferentially from oneanother. The two openings are associated with a single recessed portionand a single annular member. The at least one annular member maycomprise two O-rings, one on either side of the at least one opening.The at least one annular member may be configured to protrude from therecessed portion to space the open end of the article from the innersurface of the body. In certain embodiments, the first portion is a maleportion and is configured to be received in the article open end in use.The outside surface of the article connector may be external to the openend of the article, in use.

From yet another aspect, there is provided an article connector forconnecting an open end of an article to be sterilized to a sterilizationapparatus, the article connector comprising: a body having alongitudinal axis and an inner surface defining an axially elongate boreextending between two open ends of the body, the body having a femaleportion configured to receive therein the open end of the article, and amale portion extending from the female portion and configured to befluidly connectable to the sterilization apparatus, the elongate boreextending through the female and male portions; an annular recessedportion defined in the inner surface of the female portion extendingcircumferentially around the body, the annular recessed portion beingconfigured to at least partially receive at least one annular member;and at least one opening extending through the body of the femaleportion to form a fluid communication between the elongate bore and anouter surface of the body.

From a further aspect, there is provided an article connector forconnecting an open end of an article to be sterilized to a sterilizationapparatus, the article connector comprising: a body having alongitudinal axis and an inner surface defining an axially elongate boreextending between two open ends of the body, the body having a firstmale portion configured to be received in the open end of the article,and a second male portion extending from the first male portion andconfigured to be fluidly connectable to the sterilization apparatus, theelongate bore extending through the first male portion towards thesecond male portion; at least one annular recessed portion defined in anouter surface of the first male portion extending circumferentiallyaround the body, the at least one annular recessed portion beingconfigured to at least partially receive at least one annular member inthe at least one annular recessed portion; and at least one openingextending through the body of the first male portion to form a fluidcommunication between a mating surface of the first male portion and thearticle open end and an outer surface of the first male portion which isnot received in the article open end in use.

In certain embodiments of any of the preceding or foregoing aspects, thearticle connector further comprises the at least one annular member,wherein the at least one annular member is made of a resilient material.The at least one annular member may be a porous material allowing foringress of sterilant. The at least one annular member may comprise abody defining a matrix of interconnected pores. The at least one annularmember may comprise two O-rings, one on either side of the at least oneopening.

In certain embodiments of any of the preceding or foregoing aspects, theat least one annular member is configured to protrude from the recessedportion to space the open end of the article from the inner surface ofthe body. In certain embodiments, the inner surface defines a shoulderfrom which the open end of the article is spaced when it is received inthe body in use. The at least one opening may comprise a pair ofopenings. The pair of openings may be associated with a single recessedportion and a single annular member.

In certain embodiments of any of the preceding or foregoing aspects,sterilization of long and narrow lumen can be achieved. Multi-lumensterilization is made possible, which can be simultaneous or sequential.An article having more than two lumen can be sterilized. Simultaneoussterilization of multiple lumens of an article can translate to timesavings within the sterilization cycle. Shorter cycle times areadvantageous in that bottle necks for patient treatment may be minimizedor avoided.

In certain embodiments of any of the preceding or foregoing aspects, areal-time verification of the flow of sterilant through the articleduring the sterilization cycle can be obtained by monitoring one or moreparameters in the first and/or second chamber which could be reflectiveof a condition at the second open end of the article i.e. blockage orotherwise in the lumen. These parameters can include pressure, rate ofpressure change and sterilant concentration.

In certain embodiments of any of the preceding or foregoing aspects, theability to use hydrogen peroxide as a sterilant to effectively sterilizearticles can avoid the disadvantages associated with other sterilantssuch as ethylene oxide, which is toxic, expensive, not readily availableand requires a longer sterilization cycle to flush the toxic by-products(around 16-24 hours). Furthermore, hydrogen peroxide is considered a‘low temperature’ sterilization technique and so avoids thedisadvantages associated with heated sterilization methods which candamage the article.

The inventors have noted and overcome certain limitations of hydrogenperoxide as a sterilant which include its vulnerability to condense andtherefore reduce its fluid velocity, and its ability to decompose whichcan result in microenvironments within the load which are depleted ofsterilizing agents. In certain embodiments of the present method andapparatus, one or more of the pressure difference used to force thehydrogen peroxide vapour through the article lumen, the pre-warming ofthe lumen before exposure to the sterilant, and repeated rounds ofsterilant exposure helps to minimize or reduce the limitations ofhydrogen peroxide as a sterilant.

In certain embodiments of the present article connector, the articleconnector can be used to connect the article to be sterilized with asterilization chamber. Occlusion of the outer surface of the portion ofthe article received in the article connector can be minimized oravoided which in turn can reduce the risk of non-sterilized portions ofthe article.

Embodiments of the present technology each have at least one of theabove-mentioned object and/or aspects, but do not necessarily have allof them. It should be understood that some aspects of the presenttechnology that have resulted from attempting to attain theabove-mentioned object may not satisfy this object and/or may satisfyother objects not specifically recited herein.

It must be noted that, as used in this specification and the appendedclaims, the singular form “a”, “an” and “the” include plural referentsunless the context clearly dictates otherwise.

As used herein, the term “about” in the context of a given value orrange refers to a value or range that is within 20%, preferably within10%, and more preferably within 5% of the given value or range.

As used herein, the term “and/or” is to be taken as specific disclosureof each of the two specified features or components with or without theother. For example “A and/or B” is to be taken as specific disclosure ofeach of (i) A, (ii) B and (iii) A and B, just as if each is set outindividually herein.

As used herein, the term “container” means any type of receptacle orenclosure for receiving the article to be sterilized. The term“container” is used herein to include sealable boxes with at least oneport for allowing sterilant ingress, and wrapped trays with openings,such as baskets, which can allow sterilant ingress.

As used herein, the term “sterilant” means any form of gas, vapour orliquid matter that can kill bacteria and other living microorganisms.

Additional and/or alternative features, aspects, and advantages ofembodiments of the present technology will become apparent from thefollowing description, the accompanying drawings, and the appendedclaims.

BRIEF DESCRIPTION OF THE DRAWINGS

For a better understanding of the present technology, as well as otheraspects and further features thereof, reference is made to the followingdescription which is to be used in conjunction with the accompanyingdrawings, where:

FIG. 1 is a schematic view of an apparatus for sterilization of anarticle in accordance with an embodiment of the present technology;

FIG. 2 a is a schematic view of an apparatus for sterilization of anarticle in accordance with another embodiment of the present technology;

FIG. 2 b is a schematic view of the apparatus of FIG. 2 a and showing asterilant fluid path flow through the article according to an embodimentof the present technology;

FIG. 3 is a top, front, left side perspective view of a first chamberand a container of the apparatus of FIG. 2 , in accordance with anembodiment of the present technology, with a door of the first chamberomitted;

FIG. 4 is a top, back, left side perspective view of the container ofFIG. 3 ;

FIG. 5 is atop, front, right side perspective view of the container ofFIG. 4 , with a lid removed and including an article to be sterilizedand an article connector according to an embodiment of the presenttechnology;

FIG. 6 is a bottom, front right side perspective view of the firstchamber of FIG. 3 , with the container omitted for clarity;

FIG. 7 is a schematic view of an apparatus for sterilization of anarticle in accordance with another embodiment of the present technology;

FIG. 8 is a schematic view of an apparatus for sterilization of anarticle in accordance with a further embodiment of the presenttechnology;

FIG. 9 is a schematic view of an apparatus for sterilization of anarticle in accordance with a yet further embodiment of the presenttechnology;

FIG. 10 is a schematic view of an apparatus for sterilization of anarticle in accordance with another embodiment of the present technologyin which the second chamber is disposed inside the first chamber;

FIG. 11 is a schematic view of another embodiment of the apparatus ofFIG. 10 ;

FIG. 12 is a schematic view of a further embodiment of the apparatus ofFIG. 10 ;

FIG. 13 is a schematic view of a yet further embodiment of the apparatusof FIG. 10 ;

FIG. 14 is a flow diagram showing a method for sterilizing an articleaccording to an embodiment of the present technology;

FIG. 15 is a perspective view and an enlarged side view of an articleconnector, according to another aspect and an embodiment of the presenttechnology, when attached to an article to be sterilized;

FIG. 16 is atop, front, left side perspective view of the articleconnector of FIG. 15 ;

FIG. 17 is a longitudinal cross-sectional view of the article connectorof FIG. 15 when taken along the line A-A of FIG. 15

FIG. 18 is a schematic cross-section view of an annular member of thearticle connector of FIG. 15 , according to another embodiment of thepresent technology;

FIG. 19 is a perspective view, and an enlarged side view, of anotherembodiment of the article connector of FIG. 15 , when attached to anarticle to be sterilized;

FIG. 20 is a perspective view of the article connector of FIG. 19 ;

FIG. 21 is a longitudinal cross-sectional view of the article connectorof FIG. 19 when taken along the line B-B of FIG. 19 ;

FIG. 22 is a perspective view, and an enlarged side view, of anotherembodiment of the article connector of FIG. 15 , when attached to anarticle to be sterilized;

FIG. 23 is a perspective view of the article connector of FIG. 22 ; and

FIG. 24 is a longitudinal cross-sectional view of the article connectorof FIG. 22 when taken along the line C-C of FIG. 22 .

DETAILED DESCRIPTION

Broadly, there is provided an apparatus and a method for sterilizationof an article, the article having at least one tubular structuredefining a lumen extending through the article. For the purpose of thedetailed description below, an endoscope will be used as an example ofthe article to be sterilized. It will be apparent to those skilled inthe art that embodiments of the present apparatus and method are alsoapplicable to other articles requiring sterilization, particularlyarticles having one or more tubular structures with channels or lumenextending therethrough.

The present disclosure is not limited in its application to the detailsof construction and the arrangement of components set forth in thefollowing description or illustrated in the drawings. The disclosure iscapable of other embodiments and of being practiced or of being carriedout in various ways. Also, the phraseology and terminology used hereinis for the purpose of description and should not be regarded aslimiting. The use of “including”, “comprising”, or “having”,“containing”, “involving” and variations thereof herein, is meant toencompass the items listed thereafter as well as, optionally, additionalitems. In the following description, the same numerical references referto similar elements. The terms ‘channel’ and ‘lumen’ are usedinterchangeably herein.

Referring to FIG. 1 , there is illustrated an apparatus 10 forsterilization of an article 12. The article 12 is an endoscope 12 havinga tail portion 14 and a head portion 16. The tail portion 14 of thearticle 12 comprises a tube 18 which is configured for insertion into abody cavity, for example, having a flexible form and being sized andshaped to be received in the body cavity. Typically, the head portionsof endoscopes known in the art comprise a light guide section and acontrol section. For clarity, in the present description and drawings,only the control section 16 of the endoscope 12 is illustrated whichcomprises a head body 20 to which various functional assemblies can beattached through openings 21 such as optical devices (not shown), air orwater sources (not shown) and biopsy instrumentation (not shown). Theflexible tube 18 and the head body 20 define at least one lumen 22therein (shown as dotted lines), the lumen 22 extending between a firstopen end 24 and a second open end 26 of the article 12. For clarity, asingle lumen 22 has been illustrated in dotted lines in FIG. 1 .However, it will be appreciated that other channels through the article12 are possible, such as from the open end 24 of the tube to another oneof the openings 21 of the head body 20. Certain embodiments of thepresent apparatus 10 are suitable for sterilizing articles 12 havinglumen 22 therein of up to about 3.5 m in length and of about 1.6 mminternal diameter, and in certain embodiments for sterilizing articles12 having lumen 22 of about 0.7 mm internal diameter. It will beappreciated that the apparatus 10 is also suited for use with othershapes, sizes and configurations of the article 12 as well as forarticles without lumen.

The apparatus 10 broadly comprises a first chamber 40 for receiving thearticle 12 therein. The first chamber 40 has an outlet 42 fluidlyconnected to a pump 44 which is configured to adjust an internalpressure, P1, inside the first chamber 40, and a sterilant inlet 46which is fluidly connected to a sterilant source 48 for supplyingsterilant into the first chamber 40 to sterilize the article 12. Theapparatus 10 also comprises a second chamber 50 which is separate fromthe first chamber 40 and fluidly connected thereto by a chamberconnector 52 disposed between the first and second chambers 40, 50. Thechamber connector 52 is configured to allow fluid flow between the firstand second chambers 40, 50, and is selectively sealable to fluidlyisolate the first and second chambers 40, 50 from one another. Thechamber connector 52 may comprise a valve, or the like.

The second chamber 50 has an internal pressure, P2 which can also beadjusted. The internal pressure, P2, is adjustable by lowering thepressure P1 in the first chamber using the pump 44 whilst allowing afluid flow between the first and second chambers 40, 50. In thisembodiment, there is no direct connection between the second chamber 50and the pump 44. An article connector 54 is provided which is configuredto fluidly connect the second open end 26 of the article 12 to thesecond chamber 50, whilst the first open end 24 of the article 12remains open and unattached and in fluid communication with anatmosphere of the first chamber 40. The article connector 54 can be anysuitable adaptor-type device configured to fluidly join together twoelements. For example, the article adapter can be of a female-male,male-male or female-female connector type. In this embodiment, thearticle connector 54 has one end which is sized and shaped to fluidlyconnect to the second open end 26 of the article 12, and another endwhich is sized and shaped to fluidly connect to the chamber connector52. In FIG. 1 , the article connector 54 is illustrated as having anelongate structure but it will be appreciated that the article connector54 can be of any suitable configuration for connecting the second openend 26 of the article 12 to the chamber connector 52, to thereby connectthe article 12 to the second chamber 50 through the chamber connector52. A connection to the second chamber 50, separate from the chamberconnector 52 is also possible (not shown).

In certain embodiments, a plurality (not shown) of article connectors 54is provided for individually connecting a plurality of second open ends26 of the article 12 to the second chamber 50. In these embodiments, thechamber connector 52 is configured to be fluidly connectable to theplurality of article connectors 54, and the chamber connector 52 canfluidly connect each article connector 54 separately or together to thesecond chamber 50. Any number of article connectors 54 can be provided,such as but not limited to more than 2, 3, 4, 5, 6, 7, 8, 9 or 10.

When the article 12 is positioned within the first chamber 40 andconnected to the article connector 54, a fluid path extends from thefirst chamber 40 to the second chamber 50 through the first open end 24of the article 12, the lumen 22 of the article 12, the second open end26 of the article 12, the article connector 54 and the chamber connector52. In use, the article 12 to be sterilized is connected as describedabove to form the fluid path through the lumen 22 of the article 12.Sterilant from the sterilant source 48 is supplied to the first chamber40 and flows from the first chamber 40 into the second chamber 50through the first open end 24 of the article 12, and flows through thefluid path including the lumen 22 to the second chamber 50, therebysterilizing an inside of the article 12. The sterilant inside the firstchamber 40 is in contact with an outside of the article 12, forsterilizing an outside of the article 12.

Still with reference to FIG. 1 , the first chamber 40 is fluidlysealable having walls 41 and a door (not shown) allowing access insidethe first chamber 40 when opened, and sealing of the first chamber 40when closed. The first chamber 40 is a pressure chamber which canwithstand internal pressures of less than or more than atmosphericpressure, and is made of a material or materials capable of handlingstresses caused by a variation of the internal pressure P1 inside thefirst chamber 40. In some embodiments, the first chamber 40 is arrangedto withstand internal pressure P1 less than atmospheric pressure, suchas a vacuum, for example, less than or equal to about 2.0 Torr, 1.0Torr, 0.7 Torr, 0.6 Torr, 0.5 Torr, 0.4 Torr, or 0.3 Torr. The firstchamber 40 is compatible with the sterilant in that it does not degradeupon exposure to the sterilant, and prevents outgassing thereof. Thefirst chamber 40 is made of an aluminium alloy, but other suitablematerials could be used.

In this embodiment, the sterilant supplied by the sterilant source 48 ishydrogen peroxide (H₂O₂), and the sterilant source 48 comprises areservoir of liquid hydrogen peroxide and a vaporizer (not shown in FIG.1 ) for vaporizing the liquid hydrogen peroxide. As such, the sterilantprovided into the first chamber 40 is a vapour comprising fine dropletsof liquid hydrogen peroxide. In other embodiments, a gaseous or a liquidsterilant could be used, or a combination of any one or more of gaseous,vapour and liquid sterilants. Other suitable sterilants include, but arenot limited to ozone, nitrogen oxide, peracetic acid, chlorine dioxide,and ethylene oxide.

The second chamber 50 is fluidly sealable having walls 58 and which isarranged to withstand an internal pressure which is a vacuum or lowerthan atmospheric pressure, for example, about less than or equal toabout 0.3 Torr, 0.4 Torr, 0.5 Torr, 0.6 Torr, 0.7 Torr, 1.0 Torr or 2.0Torr. The second chamber 50 is made of a material or materials capableof handling stresses caused by a variation of the internal pressure P2inside the second chamber 50, as well as exposure to the sterilant. Thesecond chamber 50 is made of an aluminium alloy, but other suitablematerials could be used.

As illustrated in FIG. 1 , the second chamber 50 is disposed outside ofthe first chamber 40. However, in certain other embodiments (not shown),the second chamber 50 can be disposed at least partially inside thefirst chamber 40.

The manner in which the sterilant is caused to flow through the fluidpath including the article lumen 22 broadly comprises a ‘pull’ systemwhereby sterilant is pulled through the open first end 24 of the article12 by a pressure difference between the first and second chambers 40,50. A larger internal pressure P1 of the first chamber 40 causessterilant to flow to the second chamber 50 which has a lower internalpressure P2 than the first chamber 40.

A sterilization cycle of the apparatus 10 typically comprises two halfcycles of sterilant exposure. Each half cycle comprises at least oneround of sterilant exposure, and in certain embodiments each half cyclecomprises two rounds of sterilant exposure. In a first round ofsterilant exposure in the first half cycle, the first chamber 40 isfluidly sealed other than an open fluid connection between the first andsecond chambers 40, 50, and the pump 44 is operated to evacuate theatmosphere of the first chamber 40 and the second chambers 50 throughthe outlet 42 thereby reducing the pressures P1 and P2 in the first andsecond chambers 40, 50 respectively. Once the internal pressures P1 andP2 have reached a desired pressure the first and second chambers 40, 50are fluidly isolated by sealing at least the outlet 42, the connector52. The desired pressures, P1 and P2, are preferably less thanatmospheric pressure and as close as possible to a medium vacuum. Forexample, the pressures P1 and P2 are reduced to about less than or equalto about 0.3 Torr, 0.4 Torr, 0.5 Torr, 0.6 Torr, 0.7 Torr; or about 0.3to about 0.7 Torr, or about 0.4 to about 0.6 Torr.

In a first round of sterilant exposure, sterilant from the sterilantsource 48 is provided into the first chamber 40 through the sterilantinlet 46, to increase the pressure P1 in the first chamber 40. Thepressure P1 can be further increased by providing air, or any otherfluid, into the first chamber 40. Once the pressure P1 in the firstchamber 40 is greater than the pressure P2 in the second chamber and/ora predetermined pressure difference is reached, the chamber connector 52is opened to allow fluid flow therethrough. The pressure differencecauses the sterilant in the first chamber 40 to flow into the secondchamber 50 through the fluid path (from the first open end 24 of thearticle 12, through the lumen 22, the article connector 54, the chamberconnector 52 and into the second chamber 50) thereby sterilizing theinside of the article 12. The pressure difference (P1−P2) can be anysuitable gradient suitable for causing the sterilant to flow from thefirst chamber 40 to the second chamber 50, and can be adapted accordingto the dimensions of the article 12 and the apparatus 10 used. In thisembodiment, a pressure difference of about 40 Torr is used, but anysuitable pressure difference suitable for causing sterilant to flowthrough the fluid path to the second chamber 50 according to the article12 to be sterilized can also be used. In certain embodiments, a suitablepressure difference (P1−P2) is within the range of about 20 Torr toabout 60 Torr, or about 20 Torr to about 40 Torr. Once an equilibrium isreached between the pressures P1 and P2, the second chamber 50 is againisolated from the first chamber 40 to avoid a backflow from the secondchamber 50 to the first chamber 40, and this is maintained for apredetermined exposure time (which is considered to run from the momentof equilibrium pressure). In a second round of sterilant exposure, thefirst and second chambers 40, 50 are again evacuated by the pump 44through the outlet 42, the second chamber 50 is fluidly sealed, moresterilant is provided into the first chamber 40 from the sterilantsource 48 through the sterilant inlet 46 increasing the pressure P1 inthe first chamber 40. Once a predetermined pressure difference isreached between P1 and P2, the sterilant is allowed to flow through thefluid path as before. Once an equilibrium is reached between thepressures P1 and P2, the second chamber 50 is again isolated from thefirst chamber 40 and this is maintained for a predetermined exposuretime. This marks the end of the first half cycle of the sterilizationcycle. This first half cycle can be repeated as required. On completionof the entire sterilization cycle, the first chamber 40 is returned toatmospheric pressure and the sterilized article 12 removed.

The sterilization cycle may also utilize a ‘push’ system, either aloneor in combination with the ‘pull’ system described above, whereby as thesterilant is being provided into the first chamber 40, the chamberconnector 52 is configured to allow sterilant flow into the secondchamber 50. The sterilization cycle may include two half cyclesdescribed above, and more than or less than the two sterilant rounds ineach half cycle as described above.

Referring now to FIGS. 2 a to 6, a further embodiment of the apparatus10 is illustrated which differs from the apparatus of FIG. 1 in that acontainer 60 is provided for housing the article 12 (FIGS. 2 a, 2 b and3). The first open end 24 of the article 12 is free inside the container60 when housed therein. The container 60 is positionable within, andremoveable from, the first chamber 40. The container 60 is arranged toallow ingress of the sterilant into the container 60 and to prevent orminimize microbial ingress into the container 60. In certainembodiments, the container 60 maintains the sterility of the article 12,once sterilized, during and after its removal from the first chamber 40.

Referring to FIGS. 3 to 5 , the container 60 is a box 62 having lateralwalls 64 and a base 66 defining a container space 68 therein, and a lid70 for selectively restricting and allowing access to the containerspace 68. Closure means, such as latches 71, are provided for securingthe lid 70 on the box 62. In other embodiments, other closure means maybe provided such as clips, clasps, buckles, ties or the like, or thecontainer 60 may not include any closure means. In some embodiments, thelid 70 is hingedly connected to one of the walls 64 and can move betweenan open and a closed position, although it will be appreciated that thelid 70 can be connectable to the box 62 in any other way. A gasket (notshown) can be associated with either the lateral walls 64 of the box 62or the lid 70 to form a sealing engagement between the box 62 and thelid 70 when the lid 70 is in a closed position. The container 60 is madeof an aluminium alloy and the gasket is made of VITON™. The container 60and the gasket may be made of any other material compatible with thesterilant to prevent degradation when exposed thereto, such as polymershaving a low outgassing rate, e.g. polytetrafluoroethylene (PTFE) orpolypropylene (PP).

The container 60 further includes a container inlet 72 arranged to allowingress of the sterilant inside the container 60 when the lid 70 isconnected to the box 62. The container inlet 72 is a porous area in thelid 70. The porous area comprises an aperture 74 formed in the lid 70,which aperture 74 is covered with a membrane 76 which is sterilantpermeable and microorganism impermeable. The membrane 76 is asterilization wrap such as KIMGUARD™, SMARTFOLD™, HALYARD™ or any othercomparable material. In certain embodiments, the porous area is formedin one or more of the lateral walls 64 or base of the box 66 instead ofin the lid 70. In certain other embodiments, the container inlet 72comprises an array of openings (not shown) defined in the lid 70 and/orin the box 62. The size of the porous area, openings and/or theconfiguration of the membrane 76 can be selected so as to allow ingressof the sterilant inside the container 60 at a desired rate.

The container 60 also comprises a container outlet 78 (FIGS. 4 and 5 ),such as an opening extending through one of the lateral walls 64 of thecontainer 60. A container connector 80 is provided at the containeroutlet 78 for connecting the article connector 54 to the chamberconnector 52. The container connector 80 is configured at one end, on aninside of the container 60, to fluidly connect to the article connector54, via an article conduit 82 (FIG. 5 ). The container connector 80 isconfigured at the other end, on an outside of the container 60, toconnect to the chamber connector 52 (FIG. 4 ).

The container 60 includes a removeable tray or a basket (not shown) onwhich the article 12 can lie.

In certain embodiments, there is also provided a vibration mechanism(not shown) for vibrating any one or more of the tray, basket or article12 to avoid or minimize shadowing.

In some embodiments (not shown), the article connector 54 is directlyfluidly connected to the container connector 80 without the articleconduit 82. In some other embodiments (not shown), any one or more ofthe article connector 54, the article conduit 82 and the containerconnector 80 forms an integral unit i.e. the integral unit would connecttogether the article second open end 26 to the chamber connector 52.

As best seen in FIG. 5 , the container connector 80 comprises aplurality of container connector ports 84. Each container connector port84 has one end which is inside the container 60, and another end whichis outside of the container 60. On the outside of the container 60, thecontainer connector ports 84 are illustrated as extending through araised portion 86 of the lateral wall 64 (FIG. 4 ), although it will beappreciated that the raised portion is optional. Although FIGS. 2 a, 2 band 5 illustrate a single article connector 54 and a single articleconduit 82, the apparatus 10 is arranged to accommodate articles 12having a plurality of second open ends 26. When the article 12 has aplurality of second open ends 26 (and hence a plurality of lumen 22), aplurality of article connectors 54 are provided, each second open end 26having an article connector 54 attached thereto. At least one of theplurality of the container connector ports 84 is fluidly connectable toat least one of the plurality of the article connectors 54 through acorresponding article conduit 82. In FIGS. 4 and 5 , the plurality ofcontainer connector ports 84 are arranged in an array (e.g. 5×2) butother configurations are also possible. More or less than the tencontainer connector ports 84 shown are possible.

A container conduit 90 is provided to fluidly connect the containerconnector 80 to the chamber connector 52. In certain embodiments, thecontainer connector 80 includes a valve (not shown) that prevents fluidcommunication therethrough when the container conduit 90 is disconnectedfrom the container connector 80. This helps to avoid or minimize ingressof microorganisms inside the container 60 when the container 60 isremoved from the first chamber 40. In certain embodiments, the valve isreplaced by a membrane (not shown) which is sterilant permeable andmicroorganism impermeable which can help to maintain sterility withinthe container 60 when the container 60 is disconnected from the secondchamber 50.

Referring to FIG. 6 , there is shown the chamber connector 52, whenviewed through the first chamber 40, at a sterilant outlet 91 of thefirst chamber 40 through one of the first chamber walls 41. The chamberconnector 52 comprises a plurality of chamber connector ports 88 whichare arranged in an array. Configurations other than the one illustratedare also possible. At least one of the plurality of the chamberconnector ports 88 is arranged to engage with at least one of theplurality of the container connector ports 84, through the containerconduit 90. Inter-engagement between any one of the chamber connectorports 88, container connector ports 84 and container conduits 90 can beformed in any manner, such as male-female, male-male or female-femaleconnections. The fluid path extends from the first chamber 40 to thesecond chamber 50 through the first open end 24 of the article 12, thelumen 22 of the article 12, the second open end 26 of the article 12,the article connector 54, the article conduit 82, the containerconnector port 84 of the container connector 80, the container conduit90 and the chamber connector port 88.

For an article 12 having a plurality of open second ends 26, each opensecond end 26 is connected by its dedicated article connector 54 to oneof the plurality of container connector ports 84 of the containerconnector 80 which in turn is connected to one of the plurality of thechamber connector ports 88, through an associated container conduit 90.In this way, a number of parallel fluid paths are therefore defined, allextending from the open first end 24 of the article 12 then in parallel,through different second open ends 26, to different article connectors54, container connector ports 84, and chamber connector ports 88.

In certain embodiments (not shown), the connection between at least oneof the plurality of the container connector ports 84 and at least one ofthe plurality of the chamber connector ports 88 is direct, and notthrough the container conduits 90. In these embodiments, the fluid pathextends from the first chamber 40 to the second chamber 50 through thefirst open end 24 of the article 12, the lumen 22 of the article 12, thesecond open end 26 of the article 12, the article connector 54, thearticle conduit 82, the container connector ports 84, and the chamberconnector port 88. Such parallel fluid paths are defined when thearticle 12 comprises more than one second open end 26, each of which isconnected to its own associated article connector 54, its own associatedcontainer connector port 84 and its own associated chamber connectorport 88.

In embodiments not utilizing a container conduit 90, the container 60can be slid into a connecting position directly with the chamberconnector 52. For example, a recessed portion (not shown) may beprovided around the chamber connection ports 88 on the first chamberwall 41 which can receive the raised portion 86 of the containerconnector 80.

As seen in FIGS. 2 a and 2 b , each one of the chamber connector ports88 is in fluid communication with an internal volume of the secondchamber 50 through a manifold 92, and the fluid flow is controlled by achamber connector valve 93 associated with each chamber connector port88. To facilitate the ‘pull’ system mentioned above, the internal volumeof the second chamber 50 is larger than a volume of the fluid pathextending between the first open end 24 of the article 12, through thelumen 22 of the article 12 and through to the chamber connector 52.

Each chamber connector valve 93 can be selectively configured to controlthe flow of fluid between the first and second chambers 40, 50 throughindividual chamber connector ports 88. The chamber connector valves 93can be controlled separately from one another to open or close the fluidpath between the first chamber and second chambers 40, 50. When suchembodiments of the apparatus 10 are used to sterilize an article 12having a plurality of lumen 22, sequential sterilization of each lumen22 is possible. Sequential sterilization can also enable the detectionof a blockage or a fluid leak in each lumen 22, as well as at any partof the fluid path, by monitoring pressure changes during sterilant flowfrom the first chamber 40 to the second chamber 50. In the case of alumen blockage or restriction, the increase in the pressure P2 in thesecond chamber during the sterilant flow from the first chamber 40 willbe less than expected. An automated system can be provided which willraise an alarm responsive to a lower pressure increase rate relative toa predetermined pressure increase rate or range. The target pressureincrease rate can be predetermined based on the make and model of thearticle 12 being sterilized. In the same way, a fluid connection of thearticle lumen 22 to the apparatus 10 can be tested by comparing ameasured overflow rate with a target flow rate. In other embodiments,the chamber connector valves 93 can be operated to provide simultaneoussterilization of the plurality of lumen 22 of the article 12.

A by-pass conduit 94 (FIGS. 2 a and 2 b ) is provided at a by-pass inlet95 of the first chamber 40, the by-pass conduit 94 having a by-passvalve 96. The by-pass conduit 94 fluidly connects the first and secondchambers 40, 50, in a connection which is distinct from the chamberconnector 52. When the chamber connector valves 93 are closed, theby-pass conduit 94 allows evacuation of the second chamber 50 throughthe first chamber 40 without having fluid flow through the fluid pathrunning through the chamber connector port 88, the container connectorport 84, the article connector 54 and the article 12. In certainembodiments, the by-pass conduit 94 reduces the time required to reducethe pressure P2 in the second chamber 50 and to achieve the requiredpressure difference between the first and second chambers 40, 50.

As can also be seen in FIGS. 2 a and 2 b , the apparatus 10 comprises anumber of other valves for controlling fluid movement in and out of theapparatus 10. An outlet valve 98 is provided between the pump 44 and theoutlet 42 of the first chamber 40 to control the fluid connectionbetween the pump 44 and the first chamber 40, the outlet valve 98 beingconfigurable between an open and a closed position. A sterilant valve100 is provided at the sterilant inlet 46 for controlling a flow of thesterilant from the sterilant source 48 into the first chamber 40 througha sterilant vaporizer 101. A vent valve 102 is provided in an auxiliaryinlet 103 in the first chamber 40 to allow fluid to flow into the firstchamber 40 to increase the internal pressure P1 in the first chamber 40,and optionally to allow fluid to flow in and out of the first chamber 40to vent the first chamber 40. In some embodiments, the sterilant inlet46 further comprises an air valve 104 to supply air to the first chamber40 to adjust the internal pressure P1. A filter (not shown) such as ahepa filter can be provided in either or both of the sterilant inlet 46and the auxiliary inlet 103.

It is contemplated that the air valve 104 and the vent valve 102 can beused alone or in combination to adjust the pressure P1 of the firstchamber 40. Accordingly, the air valve 104 and the vent valve 102 may beprovided with different sensitivities of fluid flow such that, forexample, the vent valve 102 can provide a coarse control of the flow offluid into the first chamber 40, and the air valve 104 can provide afiner control of the fluid flow into the first chamber 40.

When the vent valve 102 and the air valve 104 are closed, the pump 44can be operated, through the outlet valve 98 when it is in the openposition, to reduce the internal pressure P1 of the first chamber 40.Opening the by-pass valve 96 will also allow reduction of the internalpressure P2 of the second chamber 50. When the desired pressure P1 isreached, the outlet valve 98 and the by-pass valve 96 can be closed tomaintain the pressure P1 in the first chamber 40 and the pressure P2 inthe second chamber 50. A pressure differential can be created betweenthe first and second chambers 40, 50 by at least one of: allowingsterilant to flow into the first chamber 40 through the sterilant inlet46, allowing air to flow into the first chamber 40 through one or bothof the sterilant inlet 46 and the auxiliary inlet 103. The chamberconnector valve(s) 93 can then be opened which causes sterilant to flowinto the container 60 and in through the first open end 24 of thearticle 12 and follow the fluid path (shown as arrows in FIG. 2 b ),namely through lumen 22, through the second open end 26, through thearticle connector 54, through the container connector 80 (if there is acontainer connector 80), through the chamber connector conduit 90.

A first atmosphere monitoring device 105 is fluidly connected to thefirst chamber 40 through a first instrumentation inlet 106 formonitoring a parameter of the atmosphere inside the first chamber 40,and a second atmosphere monitoring device 108 is fluidly connected tothe second chamber 50 through a second instrumentation inlet 109 formonitoring a parameter of the atmosphere inside the second chamber 50.The first and/or second monitoring devices 105, 108 can monitor one or acombination of different parameters, such as, but not limited to,pressure, temperature and sterilant concentration. In some embodiments,only one atmosphere monitoring device is fluidly connected to either oneor the other of the first and second chambers 40, 50. By monitoring apressure in the second chamber 50, for example, a blockage in the fluidpath can be detected which can be indicative of an incompletesterilization. Monitoring a sterilant concentration in the secondchamber 50, for example, may provide an indication of sterilizationefficacy.

The second chamber 50 further comprises a second chamber inlet 110 (FIG.2 a ) and inlet valve 111 through which warmed fluid can be provided. Inthis embodiment, the fluid is air and the second chamber inlet 110 isfluidly connectable to an air source 112 arranged to supply air to thesecond chamber 50 having a temperature of between about 30° C. and about200° C., about 60° C. to about 100° C., or about 80° C. to about 95° C.The air source 112 can provide air having any suitable temperature toallow an atmosphere inside the article lumen 22 to warm up to between aroom temperature and up to a temperature which does not adversely affectthe stability of the article 12, such as about 60° C. in the case ofendoscopes. The provision of a warmed fluid to the second chamber 50 andthrough the fluid path, particularly before sterilant flows through thefluid path, can minimize or reduce condensation of the sterilant withinthe article 12 including the lumen 22, in certain embodiments.

It is to be noted that the present technology extends to the provisionof warmed fluid, such as air, to the lumen of an article to besterilized by H₂O₂ in an apparatus which differs from the apparatus 10described herein. For example, an apparatus comprising a first chamberfor receiving the article, the first chamber having an outlet which isfluidly connectable to a pump for adjusting an internal pressure in thefirst chamber; a sterilant inlet which is fluidly connectable to asterilant source for supplying sterilant to the first chamber, thesterilant being hydrogen peroxide; and a warm fluid inlet in the firstchamber for connection to a fluid source adjusting the temperature ofthe article in use. In certain embodiments, the fluid source is warm airwhich is supplied to the first chamber before the article is exposed tothe sterilant. In certain embodiments, the first chamber may include anarticle connector for fluidly connecting the second open end of thearticle to the warm fluid inlet.

Referring now to FIG. 7 , an alternative embodiment of the apparatus 10is shown. The apparatus of FIG. 7 differs from that of FIGS. 2 a to 6 inthat the second chamber 50 comprises a plurality of compartments 114 incommunication with the manifold 92. Although eight compartments 114 areshown, any number of compartments 114 may be provided in the secondchamber 50. Each compartment 114 is in fluid communication with acorresponding chamber connector valve 93 through the manifold 92.Alternatively, each chamber connector valve 93 could be connected to anumber of different compartments 114. Each compartment 114 is alsofluidly connected to the by-pass conduit 94 by its corresponding by-passvalve 96. In this embodiment, each compartment 114 has a volume which islarger than the volume of a fluid path between the first open end 24 ofthe article 12 through an individual lumen 22 of the article 12 throughto the chamber connector valve 93. Instead of a single atmosphericmeasurement device 108, a plurality of atmospheric measurement devices(not shown) could be fluidly connected to each compartment 114 tomeasure parameters within each compartment 114, or the atmosphericpressure device 108 could be selectively fluidly connected to eachcompartment 114. Although the second chamber inlet 110, second chamberinlet valve 111 and the air source 112 are not shown in FIG. 7 , theymay also be included in the apparatus 10 of this embodiment. As in theembodiments of FIGS. 2 a to 6, the lumen 22 can be warmed beforeexposure to the sterilant to avoid sterilant condensation by providingwarm air into the second chamber 40 and allowing the warm air to flowinto the lumen 22 through the chamber connector valves 93.

Referring now to FIG. 8 , an alternative embodiment of the apparatus 10is shown. The apparatus of FIG. 8 differs from that of FIGS. 2 a to 6 inthat the pump 44 is additionally fluidly connected to the second chamber50 through a second chamber outlet 116 including an outlet valve 118 toselectively control the flow of fluid from the second chamber 50 towardsthe pump 44. Unlike the embodiments of FIGS. 1 to 7 , in the embodimentof FIG. 8 , a direct connection is provided between the pump 44 and thesecond chamber 50 allowing evacuating of the second chamber 50 directlyand not through the first chamber 40. A by-pass connector and valve isnot required in this embodiment and the first and second chambers 40, 50can be evacuated at the same time or at different times. In thisembodiment, when the outlet valve 118 is open to allow evacuation of thesecond chamber 50, the fluid connection of the second chamber 50 to thefirst chamber 40 is closed i.e. the chamber connector valves 93 areclosed. Once the first and second chambers 40, 50 are evacuated to thedesired pressure, sterilant is provided into the first chamber 40 andonce the desired pressure difference (P1−P2) is achieved, the chamberconnector valve(s) 93 are opened and the sterilant is pulled into theopen first end 24 of the article 12 and flows through the fluid path tosterilize the article 12. As before, the lumen 22 can be warmed beforeexposure to the sterilant to avoid sterilant condensation by allowingwarm air to flow into the second chamber 40 through the inlet 110 andinto the lumen 22 through the chamber connector valves 93.

Referring now to FIG. 9 , an alternative embodiment of the apparatus 10of FIG. 8 is shown, in which the second chamber 50 comprises a pluralityof compartments 114 fluidly connectable to the manifold 92 (as alsoshown in the embodiment of FIG. 7 ). However, instead of eightcompartments 114, the second chamber 50 of FIG. 9 comprises fourcompartments 114, each compartment 114 being connected to an associatedchamber connector valve 93. Each compartment 114 has an associatedsecond chamber outlet 116 and outlet valve 118 to fluidly connect eachcompartment 114 to the pump 44. In this configuration, each compartment114 can be evacuated individually and/or simultaneously. This can beperformed at the same time as the first chamber 40 evacuation by thepump 44. Although not shown, each compartment 114 can also be providedwith its own inlet (not shown) for supplying warmed fluid to the secondchamber 50 and then into the article 12 through the fluid path to warmthe article 12 before sterilization for minimizing or reducingcondensation within the article 12. Alternatively, the inlet forsupplying warm air can be provided into the manifold 92.

In FIG. 10 , the apparatus 10 differs from the apparatus of FIGS. 2 aand 2 b in that the second chamber 50 is disposed inside the firstchamber 40. Together with the manifold 92, chamber connector ports 93,by-pass conduit 94 and by-pass valve 96 and monitoring device 108, thesecond chamber 50 is contained within a sealable outer compartment 120,which can maintain an atmospheric pressure within, and which has anoutlet 122 through the first chamber wall 41. The chamber connectorports 93 fluidly connect with the manifold 92 through the outercompartment 120.

In FIG. 11 , the apparatus 10 differs from that of FIG. 10 in that thesecond chamber 50 is directly connected to the pump 44 through theoutlet 122.

In FIG. 12 , the apparatus 10 differs from the apparatus 10 of FIG. 10in that the outer compartment 120 is directly fluidly connectable to thecontainer 60. In this embodiment, the container connector ports 84 andthe chamber connector ports 88 are integrated (and labelled as 84/88 inFIG. 12 ) in that a single connector is provided which can connect thearticle second open end 26 to the second chamber 50. There is nocontainer conduit 90. The article connector 54 connects the second openend 26 of the article 12 to the article conduit 82 which is directlyconnectable to the connector port 84/88.

FIG. 13 shows an alternative embodiment to that of FIG. 12 . In theapparatus 10 of FIG. 13 , the second chamber 50 is directly connected tothe pump 44.

In further alternative embodiments (not shown), the second chamber 50may have multiple compartments 114 as previously illustrated in FIGS. 7and 9 .

For any one of the embodiments of the present apparatus 10, a kit (notshown) may be provided for retroactively converting an existingsterilization chamber into embodiments of the present apparatus 10. Thekit may comprise a replacement door or wall for the existingsterilization chamber, the door or wall including any one or more of thefeatures shown in the present drawings and described herein, includingbut not limited to the chamber connector 52, chamber connector ports 88,chamber connector valves 93, second chamber 50, atmosphere monitoringdevice 108, by-pass inlet 95, by-pass conduit 94 and by-pass valve 96,warm air source 112, warm air inlet 111, container 60, article connector54, container connectors 80, container connector ports 88, articleconduit 82 and outer compartment 120.

A method 200 for sterilization of the article 12 having the first openend 24, the second open end 26 and the lumen 22 extending therebetweenwill now be described with reference to FIG. 14 . The method 200 can beoperated, but is not limited to, using any one of the embodiments of theapparatus 10 as described herein or as illustrated in FIGS. 2 a to 13.

In a step 202, the method 200 comprises disposing the article 12 in afirst chamber 40 of the sterilization apparatus 10 with the first openend 24 in fluid communication with the first chamber 40.

In a step 204, the method 200 comprises forming a fluid path from thefirst chamber 40 to a second chamber 50 of the sterilization apparatus10 through the lumen 22 of the article 12. In other words, in step 204,the method 200 comprises forming a direct fluid path from the first openend 24 of the article 12, through the lumen 22 of the article 12 and thesecond open end 26 to the second chamber 50 through the chamberconnector 52. The second chamber 50 is selectively sealable to fluidlyisolate the first and second chambers 40, 50.

In a step 206, the method 200 comprises supplying sterilant to the firstchamber 40.

In a step 208, the method 200 comprises creating a pressure differencebetween the internal pressure P1 of the first chamber 40 and an internalpressure P2 of the second chamber 50.

In a step 210, the method 200 comprises allowing the sterilant to flowfrom the first chamber 40 to the second chamber 50 through the lumen 22of the article 12.

The method 200 will now be described in more detail. In step 202,disposing the article 12 in the first chamber 40 further compriseshousing the article 12 inside a container 60.

In step 204, forming the fluid path comprises fluidly connecting thesecond open end 26 of the article 12 to the second chamber 50, forexample via any one or more of the article connector 54, containerconnector 80 and chamber connector 52.

Before step 206, the internal pressure of one or more of the first andsecond chambers 40, 50 is reduced to less than 0.5 Torr or lower, suchas between 0.3 Torr and 0.5 Torr. This can be performed using the pump44 through the outlet 42. The second chamber 50 is evacuated through thefirst chamber 50 through the chamber connector 52 (as illustrated inFIG. 1 ), or through the by-pass conduit 94 (as illustrated in FIGS. 2 ato 9).

Before step 208, warm air can be supplied into the second chamber 50,having a temperature of between about 30° C. and about 200° C., about60° C. to about 100° C., or about 80° C. to about 95° C., such asthrough the second chamber inlet 110.

In step 208, creating the pressure difference between the internalpressure P1 of the first chamber 40 and the internal pressure P2 of thesecond chamber 50 comprises supplying the sterilant to the first chamber40 until the internal pressure P1 in the first chamber 40 is higher thanthe internal pressure P2 in the second chamber 50. In this respect,sterilant is allowed to flow from the first chamber 40 to the secondchamber 50 along the fluid path, for example by configuring the chamberconnector valve 93 in an open position. This can happen at the same timeas supplying the sterilant to the first chamber 40. Alternatively, thepressure P1 in the first chamber 40 can be allowed to build up byconfiguring the chamber connector valve 93 in a closed position duringthe supplying of the sterilant to the first chamber 40. The pressuredifference between P1 and P2 can be further increased by supplying airinto the first chamber 40, such as through the sterilant inlet 46 or theauxiliary inlet 103 of any one of FIGS. 2 a to 9. In one embodiment, airis supplied firstly through the auxiliary inlet 103, then through thesterilant inlet 46. The internal pressure P1 can be increased until atarget pressure difference (P1−P2) is reached, such as more than about20 Torr, about 20 Torr to about 60 Torr, or about 20 Torr to about 40Torr, or any other pressure difference for causing the sterilant to flowfrom the first chamber 40 to the second chamber 50.

In step 210, the chamber connector valve 93 is configured in an openposition to allow the sterilant to flow from the first chamber 40 to thesecond chamber 50. When there are a plurality of chamber connector ports88 each having its associated chamber connector valve 93 (as illustratedin FIGS. 2 a to 9), and each of the chamber connector ports 88 beingfluidly connected to each one of a plurality of lumen 22 of the article12, the chamber connector valves 93 are configured in an open positionto allow the sterilant to flow from the first chamber 40 to the secondchamber 50 through the plurality of lumen 22. The chamber connectorvalves 93 can be opened at the same time, individually or in batches.The chamber connector valves 93 close after reaching an equilibrium inpressure. The article 12 is then maintained in contact with thesterilant for an exposure interval. After the exposure interval haslapsed, during which time the article is exposed to the sterilant, thefirst and second chambers 40, 50 are exhausted once more, such asthrough the outlet 42 by the pump 44. In this embodiment, steps 206 to210 are then repeated to complete a first half-cycle, but a singleexposure or more than 2 exposures may also be possible. A fullsterilization cycle comprises two such half-cycles. At the end of thefull sterilization cycle, the container 60 is disconnected from thefirst chamber 40. This can help to ensure sterility. Alternatively, thecontainer outlet 78 can comprise one or more valves (not shown)automatically closing after the sterilization cycle is completed andprior to the opening of the first chamber 40. The closing of the one ormore valves may be triggered by a pressure change or by a command. Thesterilization cycle may be at least partially automated.

A parameter of the atmosphere in the first or the second chamber 40, 50can be monitored at any time throughout the method 200. For example, inone embodiment, various parameters of the atmosphere in the secondchamber 50 are monitored using the atmosphere monitoring device 108 asthe sterilant is flowing through the article lumen 22 into the secondchamber 50. These parameters include a pressure, which can indicate ablockage in the lumen 22 and/or a sterilant concentration to provide anindication of the efficacy of the sterilization process. On detection ofa reduced pressure or a reduced concentration of the sterilant below apre-set value, the method if it is automated may stop automatically, oran alarm be raised.

Certain embodiments of the technology are illustrated by the followingnon-limiting example.

EXAMPLES Example 1: Sterilization Efficacy of Embodiments of theApparatus and Method

An embodiment of the apparatus 10 according to FIGS. 2 a and 2 b wasused to sterilize an article 12 comprising a tube made of PTFE of 3.5 mlength having a lumen 22 extending therethrough with an internaldiameter of approximately 1.6 mm. The article 12 was placed in thecontainer 60 which was a tray wrapped in a sterile wrap made ofpolypropylene and having pores which allowed ingress of sterilant (seeExample 2 below). One end of the tube was connected to the container 60using the article connector 54, and the article connector 54 wasconnected to the second chamber 50. Sterility was assessed in onelocation (the most challenging site) at the end of the 3.5 m tube nextto the second chamber 50, by placing a biological indicator consistingof 2×10⁶ Bacillus Stearothermophilus spores inoculated on a stainlesssteel wire inside the lumen 22. The sterilization cycle of FIG. 14 , inwhich steps 206 to 210 were repeated two times (equivalent to onehalf-cycle), was applied to the apparatus 10 using H₂O₂ vapour as thesterilant. At the end of the sterilization cycle, the stainless steelwire was retrieved from the lumen 22 of the tube and cultured in growthmedium for 14 days, and the spore viability was assessed by anindication of turbidity by visual evaluation. The test was repeated 40times. A positive control comprised an inoculated stainless steel wirein a lumen which was not sterilized. A negative control comprised asterile uninnoculated stainless steel wire incubated in growth medium. Agrowth media sterility control was also performed. The results (averageof 40 repeats) are shown in Table 1.

TABLE 1 presence of viable organisms on a stainless steel wire insertedin the lumen of the article 12, when cultured for 14 days, after asterilization cycle. Recovery of viable organisms (Day) Test 7 14 40repeats  0/40  0/40 Positive control 8/8 8/8 Negative control 0/1 0/1

The results showed that the apparatus and the method effectivelysterilized the article when compared to a positive and a negativecontrol.

An article connector 300 will now be described with reference to FIGS.15 to 24 . The article connector 300 can be used with any othersterilization apparatus or system requiring a removeable fluidconnection between an end of an article to be sterilized and thesterilization apparatus or a portion of a sterilization apparatus. Thearticle connector 300 can be considered as a type of adaptor for fluidlyconnecting an article to be sterilized to a sterilization apparatus or aportion of a sterilization apparatus. For example, the article connector300 can be used with the apparatus 10 and the method 200 as illustratedin any one of FIGS. 1 to 14 , as the article connector 54, but its useis not limited as such.

Referring initially to FIG. 15 , the article connector 300 is fluidlyand removably connectable to an article 302 to be sterilized. Thearticle 302 is an endoscope 302 having a tail portion 304 (shownpartially in FIG. 15 ) and a head portion 306, but can be any otherarticle requiring sterilization. The tail portion 304 of the article 302comprises a tube (not shown) which is configured for insertion into abody cavity, for example, having a flexible form and being sized andshaped to be received in the body cavity. The head portion 306 comprisesa head body 310 to which various functional assemblies can be attachedthrough openings such as optical devices (not shown), air or watersources (not shown) and biopsy instrumentation (not shown). The flexibletube and the head body 310 define at least one lumen 311 therein (FIG.17 ), the lumen 311 extending between a first open end 312 and a secondopen end 314 of the article 302.

As best seen in FIGS. 16 and 17 , the article connector 300 has a body316 with a bore 318 defined therein by an inner surface 320 of the body316, the bore 318 extending between a first end 322 and a second end 324of the article connector 300, the first and second ends 322, 324 beingopen. The article connector 300 and the bore 318 have a longitudinalaxis 326.

The body 316 comprises a female portion 328 at the first end 322 and amale portion 330 at the second end 324, aligned along the longitudinalaxis 326. The elongate bore 318 extends through the female and maleportions 328, 330. The female portion 328 of the body 316 is configuredto receive therein the second open end 314 of the article 302. The maleportion 330 extends from the female portion 328 and is configured to beconnected to the sterilization apparatus, such as the article conduit 82of FIGS. 2 to 9 . A distal tip 332 of the male portion 330 is flanged onan outer surface 334 of the body 316. This configuration may assist inretention of the male portion 330 of the article connector 300 in acorresponding opening (not shown) of the sterilization apparatus towhich it is to be fluidly connected. The female and male portions 328,330 are substantially cylindrical, with the female portion 328 having anouter diameter 336 which is larger than an outer diameter 338 of themale portion 330. An inner diameter 340 of the bore 318 is also largerin the female portion 328 than in the male portion 330 of the body 316.Inside the body 316, at the junction of the female and male portions328, 330, the inner surface 320 defines a transverse shoulder 342 fromwhich the second open end 314 of the article 302 is spaced when receivedin the body 316, in use.

A plurality of openings 344 are defined in the body 316, each opening344 extending through the body 316 between the inner and outer surfaces320, 334 to form a fluid communication between the bore 318 and theouter surface 334 of the body 316. The openings 344 are spacedcircumferentially around the body 316. In FIG. 16 , there are threeopenings 344 visible (with one of the openings being partially visible).However, it will be appreciated that more or less than three openings344 extending through the body 316 may be provided. In FIG. 17 , thecross-section through the body 316 is taken along the line A-A shown inFIG. 15 .

In the female portion 328, the inner surface 320 has two recessedportions 346, which are annular and extend circumferentially about thebody 316 and axially aligned with the body 316. The two recessedportions 346 are axially spaced apart from one another. Each recessedportion 346 is channel-like and configured to at least partially receivean annular member 348. Instead of the two recessed portions 346, thearticle connector 300 may have one annular recessed portion 346 or morethan two annular recessed portions 346 (not shown).

Each annular member 348 is made of a resilient material and is sized andshaped to allow contact between an outer surface 350 (FIG. 17 ) of thearticle second open end 314 when the article second open end 314 isreceived in the female portion 328. This can aid in retention and/oralignment of the article second open end 314 in the bore 318 of thefemale portion 328 in use. The annular member 348 may be made of anon-porous compatible material, such as VITON™. The annular member 348may have an interconnected porous structure allowing for ingress ofsterilant, and can be made of any open cell material such as poroussilicon, porous PTFE, synthetic rubber such as VITON™, or any othercompatible material.

Each corresponding annular member 348 and recessed portion 346 isconfigured so that at least a portion of the annular member 348protrudes out of the recessed portion 346 in use, i.e. when the articlesecond open end 314 is in position in the female portion 328, at least aportion of the annular member 348 protrudes out of the recessed portion346 and spaces the outer surface 350 of the article second open end 314from the inner surface 320 of the body 316. In use, this configurationcan provide a continuous fluid path around the second open end 314 ofthe article 302 received in the female portion 328. The continuous fluidpath is defined by a space between the outer surface 350 of the articlesecond open end 314 and the inner surface 320 of the female portion 328of the body 316, and a fluid path through the interconnecting poresthrough at least a portion of the annular member 348.

In use, when the article connector 300 is fluidly connected to thearticle second open end 314, a sterilant such as hydrogen peroxide canbe caused to flow through the lumen 311 of the article 302 and throughthe bore 318 of the article connector 300. As the sterilant flowsthrough the bore 318 of the article connector 300 as well as beingpresent around the outside of the article 302, the outer surface 350 ofthe article second open end 314 is also sterilized. Therefore, accordingto certain embodiments of the article connector 300, occluded areas ofthe article 302 which are received within the article connector 300which the sterilant cannot contact are minimized or avoided.

FIG. 18 shows an alternative embodiment of the annular member 348 ofFIG. 17 , wherein the annular member 348 has lateral sides 352 which aresealed which can force fluid flow (indicated by the arrows) through theunsealed sides 354 to contact the outer surface 350 of the articlesecond open end 314.

FIGS. 19 to 21 show another embodiment of the article connector 300,which differs from the article connector 300 of FIGS. 15 to 17 in that apair of openings 344 is provided extending through the body 316 insteadof a single opening 344. Instead of a recessed portion 346 which isassociated with a single one of the openings 344, in this embodiment,the single annular recessed portion 346 is associated with the pair ofopenings 344. A single annular member 348 is provided in the recessedportion 346 and is in fluid communication with the pair of openings 344.This configuration can be better suited for smaller article connectors300 in which the use of two separate annular members 348 such as o-ringsor disks may not be possible. As with the embodiment of FIGS. 15 to 17 ,the annular members can be porous.

FIGS. 22 to 24 show another embodiment of the article connector 300,which differs from the article connector 300 of FIGS. 15 to 17 in thatthe female portion 328 of FIGS. 15 to 17 is a male portion 328 in FIGS.22 to 24 and is arranged to be inserted inside the article lumen 311.The recessed portion 346 and the annular members 348 are located on theouter surface 334 of the article connector 300, allowing insertioninside the article second open end 314. A single annular recessedportion 346 and annular member 348 may be provided instead of the twoshown. The openings 344 extend from the outer surface 334 of the maleportion 328 through the body 316 and extend to a portion of the articleconnector 300 which will be in contact with the sterilant in use. Theopenings 344 are positioned between the recessed portions 346 andarranged to allow ingress of the sterilant to a mating surface betweenthe annular members 348, thus exposing the mating surface to sterilantwhen in use. As before, the annular members 348 can be porous.

Modifications and improvements to the above-described embodiments of thepresent technology may become apparent to those skilled in the art. Theforegoing description is intended to be exemplary rather than limiting.The scope of the present technology is therefore intended to be limitedsolely by the scope of the appended claims.

1-19. (canceled)
 20. A sterilization apparatus for sterilizing anarticle having a lumen with sterilant, the sterilization apparatus: afirst chamber sized and shaped to receive the article, the first chamberhaving a sterilant inlet configured to be fluidly connected to asterilant source for supplying sterilant to the first chamber; a secondchamber having a flow opening; an article connector configured to coupleto the article and fluidly connect to the lumen of the article, thearticle connector being fluidly connectable to the second chamberthrough the flow opening to form a fluid path along which sterilantflows from the first chamber to the second chamber through the lumen ofthe article and through the flow opening when the article is disposed inthe first chamber and sterilant is introduced into the first chamber viathe sterilant inlet; and a warm fluid inlet configured to be fluidlyconnected to a warm fluid source for supplying warm fluid, the warmfluid inlet being fluidly connectable to the article connector to permitwarm fluid to flow through the lumen of the article to warm the lumen ofthe article.
 21. The sterilization apparatus of claim 20, wherein thesecond chamber includes the warm fluid inlet, the warm fluid inletarranged to supply warm fluid to the second chamber.
 22. Thesterilization apparatus of claim 20, wherein the first chamber includesthe warm fluid inlet, the warm fluid inlet arranged to supply warm fluidto the first chamber.
 23. The sterilization apparatus of claim 20,further comprising the warm fluid source, the warm fluid source fluidlyconnected to the warm fluid inlet.
 24. The sterilization apparatus ofclaim 23, wherein the warm fluid source comprises a warm air sourceconfigured to supply warm air to the warm fluid inlet.
 25. Thesterilization apparatus of claim 24, wherein the warm air source isconfigured to supply warm air having a temperature between about 30° C.to about 200° C.
 26. The sterilization apparatus of claim 24, whereinthe warm air source is configured to supply warm air having atemperature between about 60° C. to about 100° C.
 27. The sterilizationapparatus of claim 24, wherein the warm air source is configured tosupply warm air having a temperature between about 80° C. to about 95°C.
 28. The sterilization apparatus of claim 20, further comprising apump arranged to create a pressure difference between the first andsecond chambers.
 29. The sterilization apparatus of claim 28, whereinthe first chamber includes a pump opening, the pump fluidly connected tothe pump opening for adjusting an internal pressure of the firstchamber.
 30. The sterilization apparatus of claim 20, further comprisingthe sterilant source, the sterilant source fluidly connected to thesterilant inlet.
 31. The sterilization apparatus of claim 20, furthercomprising an article container sized and shaped to receive the article,the first chamber sized and shaped to receive the article container, thearticle container having a container inlet arranged to allow the egressof sterilant from the first chamber, the article container having acontainer outlet being fluidly connectable to the article connectoralong the flow path such that sterilant flows from the first chamber tothe second chamber through the container outlet when the article isdisposed in the article container and the article container is disposedin the first chamber.
 32. The sterilization apparatus of claim 20,further comprising a valve along the flow path between the first andsecond chambers, the valve being configurable between an open positionand a closed position for providing fluid communication and isolation,respectively, between the first and second chambers.
 33. A method forsterilizing an article having a lumen with a sterilant, the methodcomprising: placing the article in a first chamber of a sterilizationapparatus; flowing a warm fluid through the lumen of the article;supplying the sterilant to the first chamber; and flowing the sterilantthrough the lumen of the article to sterilize the article.
 34. Themethod of claim 33, wherein the sterilant is supplied to the firstchamber in a vapour form, and wherein said flowing the warm fluid occursbefore said flowing the sterilant to warm the lumen and minimizecondensation of the sterilant in the lumen during said flowing thesterilant.
 35. The method of claim 33, further comprising creating apressure difference between the first chamber and a second chamber,wherein said flowing the sterilant includes moving the sterilant underthe influence of the pressure difference moving towards equilibriumbetween the first chamber and the second chamber.
 36. The method ofclaim 35, wherein said flowing the warm fluid occurs during saidcreating the pressure difference, the warm fluid flowing through thelumen of the article due to said creating the pressure difference. 37.The method of claim 35, wherein said moving the sterilant includesopening a valve to provide fluid communication between the first andsecond chambers to permit the pressure difference to move towards saidequilibrium.
 38. The method of claim 33, further comprising placing thearticle in an article container and placing the article container, withthe article therein, in the first chamber, wherein said flowing thesterilant includes flowing the sterilant through the article container.39. The method of claim 33, wherein the warm fluid comprises warm airhaving a temperature between about 30° C. to about 200° C.